Methods and apparatus for fabricating leads with conductors and related flexible

Patent metadata

Field	Value
Publication number	US-9248270-B2
Application number	US-4783208-A
Country	US
Kind code	B2
Filing date	Mar 13, 2008
Priority date	Mar 19, 2007
Publication date	Feb 2, 2016
Grant date	Feb 2, 2016

Abstract

MRI/RF compatible leads include at least one conductor, a respective conductor having at least one segment with a multi-layer stacked coil configuration. The lead can be configured so that the lead heats local tissue less than about 10 degrees Celsius (typically about 5 degrees Celsius or less) or does not heat local tissue when a patient is exposed to target RF frequencies at a peak input SAR of at least about 4 W/kg and/or a whole body average SAR of at least about 2 W/kg. Related leads and methods of fabricating leads are also described.

First claim

That which is claimed:

1. An RF/MRI compatible lead having a proximal end and a distal end, the lead comprising:
an outer layer of a biocompatible, non-conductive polymer material extending along a portion of the lead;
at least one electrode disposed along the distal end of the lead;
at least one insulated conductor extending along the lead and electrically coupled to the at least one electrode, each of the at least one insulated conductor having a length with opposing distal and proximal end portions, each of the at least one insulated conductor having at least one segment with a multi-layer coil configuration, each multi-layer coil configuration being covered by the outer layer of the biocompatible, non-conductive polymer material and being formed from a single one of the at least one insulated conductor and comprising a first forward coiled section that extends in a forward lengthwise direction for a first forward physical length, then turns to merge into a proximately positioned reverse coiled section that extends in a substantially opposing reverse lengthwise direction for a reverse physical length, then turns to merge into a proximately positioned second forward coiled section that extends in the forward lengthwise direction for a second forward physical length, wherein the first forward coiled section, reverse coiled section, and second forward coiled section of the multi-layer coil configuration are each part of the single one of the at least one insulated conductor,
wherein the lead is flexible and is configured and arranged for insertion into a body of a patient.

2. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, at least two of the first forward section, the second forward section, and the reverse coiled section have substantially constant diameter coil configurations.

3. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section, the second forward coiled section and the reverse coiled section are substantially concentric.

4. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, at least some revolutions of the first forward and reverse coiled sections reside proximate each other in a side-to-side lengthwise orientation.

5. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, at least some revolutions of the reverse coiled section reside proximate and over the first forward coiled section.

6. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, at least some revolutions of the reverse coiled section are interleaved with at least some revolutions of at least one of the first or second forward coiled sections.

7. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section extends in the forward lengthwise direction about a central axis and has a pitch such that serial revolutions of the first forward coiled section are spaced apart in a lengthwise direction to define gaps, and wherein the reverse coiled section extends about the central axis and has a pitch such that revolutions thereof substantially reside in the gaps of the first forward coiled section.

8. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, the second forward coiled section has more revolutions than that of the first forward and the reverse coiled sections.

9. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section resides on a first layer, the reverse coiled section resides on a second layer over the first layer, and the second forward coiled section resides on a third layer over the second layer to define a three-layer stacked conductor coil configuration.

10. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section and the reverse coiled section reside on a substantially common layer and the second forward coiled section resides over the first forward and reverse coiled sections to define a two-layer stacked conductor coil configuration.

11. A lead according to claim 1 , wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section and the reverse coiled section have substantially the same pitch, and wherein the second forward coiled section has a smaller pitch than that of the first and reverse coiled sections.

12. A lead according to claim 1 , wherein each of the at least one conductor has at least one segment with a multi-layer stacked coil configuration of at least one set of the first and second forward coiled sections and the reverse coiled section.

13. A lead according to claim 12 , wherein, for the multi-layer coil configuration of at least one of the at least one segment of at least one of the plurality of conductors, the first forward coiled section and the reverse coiled section have substantially the same pitch, and wherein the second forward coiled section has a smaller pitch than that of the first and reverse coiled sections.

14. A lead according to claim 1 , wherein at least one segment of the multi-layer coil configuration has more than three layers of stacked coils.

15. A lead according to claim 1 , wherein the at least one conductor is a plurality of conductors wherein each of the conductors are insulated along an entire length of the lead forming the multi-layer coil configuration.

16. A lead according to claim 1 , wherein the lead has a length and at least a major portion of the length of the lead has a substantially constant outer diameter.

17. A lead according to claim 1 , further comprising an elongate inner flexible sleeve residing about a central lengthwise axis with the multi-layer coil configuration encircling the sleeve.

18. A lead according to claim 1 , wherein the at least one conductor includes a conductor that has a cross-sectional width of between about 0.0001 inches to about 0.2 inches.

19. A lead according to claim 1 , wherein the lead is an MRI/MRS compatible implantable medical lead.

20. A lead according to claim 1 , wherein the at least one conductor is a plurality of conductors and the at least one electrode is a plurality of electrodes.

21. A lead according to claim 20 , wherein each of the plurality of electrodes is electrically coupled to a different one of the plurality of conductors.

22. A lead according to claim 1 , wherein each of the at least one conductor has low DC resistance.

23. A lead according to claim 1 , wherein the conductor has at least two segments of the multi-layer coil configuration, and wherein a forward section on a top layer of one multi-layer coil configuration in one segment merges into a forward section on a bottom layer of the other segment.

24. A lead according to claim 1 , wherein the at least one conductor is a plurality of conductors, and wherein each of the plurality of conductors is a continuous length of conductor.

25. A lead according to claim 1 , wherein the at least one conducto

Assignees

• Karmarkar Parag V
• Bottomley Paul A
• Allen Justin M
• Edelstein William A
• Piferi Peter
• Gore Brian
• Boston Scient Neuromodulation
• Mri Interventions Inc

Inventors

• Karmarkar Parag V
• Bottomley Paul A
• Allen Justin M
• Edelstein William A
• Piferi Peter
• Gore Brian

Classifications

• B29C33/126

  using centering means forming part of the insert · CPC title

• Y10T29/49071

  by winding or coiling · CPC title

• A61N1/086

  Magnetic resonance imaging [MRI] compatible leads · CPC title

• B29L2031/753

  Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008) · CPC title

• A61N1/05 Primary

  for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) · CPC title